Table 3:
Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | |
---|---|---|---|---|
Any treatment-emergent adverse event | 77 (99%) | 33 (42%) | 4 (5%) | 2 (3%) |
Fatigue | 32 (41%) | 1 (1%) | 0 | 0 |
Diarrhoea | 21 (27%) | 0 | 0 | 0 |
Pruritus | 21 (27%) | 0 | 0 | 0 |
Nausea | 17 (22%) | 0 | 0 | 0 |
Cough | 15 (19%) | 0 | 0 | 0 |
Abdominal pain | 11 (14%) | 0 | 0 | 0 |
Rash* | 10 (13%) | 0 | 0 | 0 |
Vomiting | 9 (12%) | 1 (1%) | 0 | 0 |
Actinic keratosis | 8 (10%) | 0 | 0 | 0 |
Anaemia | 8 (10%) | 1 (1%) | 0 | 0 |
Back pain | 8 (10%) | 0 | 0 | 0 |
Constipation | 8 (10%) | 0 | 0 | 0 |
Dry skin | 8 (10%) | 0 | 0 | 0 |
Hypothyroidism | 8 (10%) | 0 | 0 | 0 |
Maculopapular rash* | 8 (10%) | 0 | 0 | 0 |
Arthralgia | 7 (9%) | 1 (1%) | 0 | 0 |
Basal cell carcinoma | 7 (9%) | 1 (1%) | 0 | 0 |
Dyspnoea | 6 (8%) | 1 (1%) | 0 | 0 |
Hypokalaemia | 5 (6%) | 1 (1%) | 0 | 0 |
Pain in extremity | 5 (6%) | 1 (1%) | 0 | 0 |
Wound infection | 5 (6%) | 1 (1%) | 0 | 0 |
Dizziness | 4 (5%) | 1 (1%) | 0 | 0 |
Increased aspartate aminotransferase | 4 (5%) | 1 (1%) | 0 | 0 |
Skin infection | 4 (5%) | 1 (1%) | 0 | 0 |
Urinary tract infection | 4 (5%) | 2 (3%) | 0 | 0 |
Fall | 3 (4%) | 2 (3%) | 0 | 0 |
Hyperglycaemia | 3 (4%) | 3 (4%) | 0 | 0 |
Neck pain | 3 (4%) | 1 (1%) | 0 | 0 |
Pain | 3 (4%) | 1 (1%) | 0 | 0 |
Pneumonitis | 3 (4%) | 1 (1%) | 2 (3%) | 0 |
Squamous cell carcinoma of skin | 3 (4%) | 1 (1%) | 0 | 0 |
Hypertension | 2 (3%) | 6 (8%) | 0 | 0 |
Hyponatraemia | 2 (3%) | 2 (3%) | 0 | 0 |
Hypotension | 2 (3%) | 1 (1%) | 0 | 0 |
Muscular weakness | 2 (3%) | 2 (3%) | 0 | 0 |
Musculoskeletal pain | 2 (3%) | 2 (3%) | 0 | 0 |
Cellulitis | 1 (1%) | 3 (4%) | 0 | 0 |
Hypophosphataemia | 1 (1%) | 1 (1%) | 0 | 0 |
Influenza | 1 (1%) | 1 (1%) | 0 | 0 |
Lymphopenia | 1 (1%) | 2 (3%) | 0 | 0 |
Pneumonia | 1 (1%) | 3 (4%) | 1 (1%) | 1 (1%) |
Soft tissue infection | 1 (1%) | 1 (1%) | 0 | 0 |
Squamous cell carcinoma | 1 (1%) | 1 (1%) | 0 | 0 |
Atopic dermatitis | 0 | 1 (1%) | 0 | 0 |
Autoimmune hepatitis | 0 | 1 (1%) | 0 | 0 |
Breast cancer | 0 | 2 (3%) | 0 | 0 |
Cholecystitis | 0 | 1 (1%) | 0 | 0 |
Clostridium difficile colitis | 0 | 1 (1%) | 0 | 0 |
Death | 0 | 0 | 0 | 1 (1%) |
Device-related infection | 0 | 1 (1%) | 0 | 0 |
Encephalitis | 0 | 1 (1%) | 0 | 0 |
Extradural abscess | 0 | 1 (1%) | 0 | 0 |
Facial neuralgia | 0 | 1 (1%) | 0 | 0 |
Hepatitis | 0 | 1 (1%) | 0 | 0 |
Hip fracture | 0 | 1 (1%) | 0 | 0 |
Increased international normalised ratio | 0 | 1 (1%) | 0 | 0 |
Increased lipase | 0 | 1 (1%) | 0 | 0 |
Increased weight | 0 | 1 (1%) | 0 | 0 |
Myocardial infarction | 0 | 0 | 1 (1%) | 0 |
Myocarditis | 0 | 1 (1%) | 0 | 0 |
Nasal cavity cancer | 0 | 1 (1%) | 0 | 0 |
Positive influenza A virus test | 0 | 1 (1%) | 0 | 0 |
Pneumonia influenza | 0 | 1 (1%) | 0 | 0 |
Proctitis | 0 | 1 (1%) | 0 | 0 |
Psoas abscess | 0 | 1 (1%) | 0 | 0 |
Radius fracture | 0 | 1 (1%) | 0 | 0 |
Sepsis | 0 | 1 (1%) | 1 (1%) | 0 |
Staphylococcal infection | 0 | 1 (1%) | 0 | 0 |
Subdural haematoma | 0 | 1 (1%) | 0 | 0 |
Syncope | 0 | 1 (1%) | 0 | 0 |
Upper abdominal pain | 0 | 1 (1%) | 0 | 0 |
Urinary tract obstruction | 0 | 1 (1%) | 0 | 0 |
Wound complication | 0 | 1 (1%) | 0 | 0 |
Data are n (%) in all treated patients. Treatment-emergent adverse events, regardless of attribution, reported in at least 10% of patients (grades 1–2) or by any patient (grades 3–5) are shown.
Although rash and maculopapular rash might reflect the same condition, they were listed as two distinct events for the safety report of the study.